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Document L:2023:151:FULL
Official Journal of the European Union, L 151, 12 June 2023
Official Journal of the European Union, L 151, 12 June 2023
Official Journal of the European Union, L 151, 12 June 2023
ISSN 1977-0677 |
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Official Journal of the European Union |
L 151 |
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English edition |
Legislation |
Volume 66 |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
12.6.2023 |
EN |
Official Journal of the European Union |
L 151/1 |
COMMISSION REGULATION (EU) 2023/1141
of 1 June 2023
refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,
Whereas:
(1) |
Pursuant to Regulation (EC) No 1924/2006, health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in the Union list of permitted health claims. |
(2) |
Regulation (EC) No 1924/2006 also provides that applications for authorisation of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (‘the Authority’). |
(3) |
Following the receipt of an application, the Authority is to inform without delay the other Member States and the Commission, and to deliver an opinion on the health claim concerned. |
(4) |
The Commission is to decide on the authorisation of the health claim taking into account the opinion delivered by the Authority. |
(5) |
Following an application from Nestlé S.A., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447). The claim proposed by the applicant was worded as follows: ‘Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal’. |
(6) |
On 8 April 2021, the Commission and the Member States received the scientific opinion (2) on that claim from the Authority, which concluded that, on the basis of the data presented, the effect of beta-glucans in reducing post-prandial blood glucose responses is well established. However, the evidence provided had been insufficient to establish an effect on reduction of post-prandial glycaemic responses at doses of 1,3 g beta-glucans per 25 g of available carbohydrate incorporated into ready-to-eat breakfast cereals manufactured by pressure cooking (i.e. either batch cooking or extrusion), as requested by the applicant. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
(7) |
Following an application from Pharmactive Biotech Products, S.L., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Affron® and the contribution to the maintenance of a healthy mood (Question No EFSA-Q-2020-00617). The claim proposed by the applicant was worded as follows: ‘Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings’. |
(8) |
On 6 July 2021, the Commission and the Member States received the scientific opinion (3) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of Affron® and increase in positive mood. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
(9) |
Following an application from Praline i Cokolada j.d.o.o., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to MegaNatural®-BP grape seed extract and the maintenance of normal blood pressure (Question No EFSA-Q-2020-00718). The claim proposed by the applicant was worded as follows: ‘MegaNatural®-BP helps maintain healthy blood pressure’. |
(10) |
On 9 August 2021, the Commission and the Member States received the scientific opinion (4) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of MegaNatural®-BP, a grape seed extract standardised for total phenolics, gallic acid and the sum of catechin and epicatechin content, and maintenance of normal blood pressure. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
(11) |
Following an application from Sensus B.V. (Royal Cosun), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and the maintenance of normal defecation (Question No EFSA-Q-2020-00631). The claim proposed by the applicant was worded as follows: ‘Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency’. The applicant also provided three alternative wordings for the claim. |
(12) |
On 12 August 2021, the Commission and the Member States received the scientific opinion (5) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Frutalose® and the maintenance of normal defecation under the proposed conditions of use. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
(13) |
The comments by Nestlé S.A. on the Authority’s opinion on the health claim relating to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447), received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have been considered when adopting this Regulation. |
(14) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted health claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 404, 30.12.2006, p. 9.
(2) EFSA Journal 2021;19(4):6493.
(3) EFSA Journal 2021;19(7):6669.
(4) EFSA Journal 2021;19(8):6776.
(5) EFSA Journal 2021;19(8):6775.
ANNEX
Rejected health claims
Application – Relevant provisions of Regulation (EC) No 1924/2006 |
Nutrient, substance, food or food category |
Claim |
EFSA opinion reference |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data |
Beta-glucans sourced from oats and/or barley, incorporated into ready-to-eat breakfast cereals manufactured via pressure cooking (i.e. either by batch cooking or extrusion), and present at a level of at least 1,3 g per 25 g available carbohydrate in the ready-to-eat cereal |
Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal |
Q-2020-000447 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data |
Affron®, aqueous saffron extract, with the sum of crocins and safranal concentration > 3,5 % and dextrin as inert carrier |
Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings |
Q-2020-00617 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data |
MegaNatural®-BP grape seed extract made entirely of California-grown grapes containing biologically active constituents: total phenolics (90–93 %), gallic acid (≥ 2 %) and catechin and epicatechin (≥ 5 %). The distribution of phenolic compounds in the MegaNatural®-BP is on average 9 % monomers, 69 % oligomers and 22 % polymers |
MegaNatural®-BP helps maintain healthy blood pressure |
Q-2020-00718 |
Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data |
Frutalose® chicory oligofructose |
Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency (And three other alternative wordings) |
Q-2020-00631 |
12.6.2023 |
EN |
Official Journal of the European Union |
L 151/5 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1142
of 9 June 2023
amending Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 as regards the quantities that may be imported under certain tariff quotas following the agreement between the European Union and the United States of America
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 187 thereof,
Whereas:
(1) |
Commission Implementing Regulation (EU) 2020/761 (2) lays down the rules for the management of import and export tariff quotas for agricultural products managed by a system of import and export licences and provides for specific rules. |
(2) |
Commission Implementing Regulation (EU) 2020/1988 (3) lays down the rules for the administration of import tariff quotas designed to be used following the chronological order of dates of acceptance of customs declarations (‘first come, first served’ principle). |
(3) |
The Agreement between the European Union and the United States of America pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom`s withdrawal from the European Union, concluded by Council Decision (EU) 2023/912 (4), amends the quantities of products to be imported under some tariff quotas opened in favour of the United States and some tariff quotas opened for all other countries. The tariff quotas with following order numbers are concerned: 09.0035, 09.0040, 09.0041, 09.0055, 09.0056, 09.0059, 09.0070, 09.0073, 09.0083, 09.0089, 09.0093, 09.0094, 09.0123, 09.0147, 09.4002, 09.4038, 09.4116, 09.4123, 09.4127 and 09.4170. |
(4) |
The amendments made by that Agreement should be reflected in Annexes to Implementing Regulations (EU) 2020/761 and (EU) 2020/1988. |
(5) |
Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 should therefore be amended accordingly. |
(6) |
Transitional provisions are needed to clarify how to handle the situations that may arise as a result of the amendments of quantities of products to be imported under the tariff quotas concerned. This concerns tariff quotas that are managed in periods divided into sub-periods. It also concerns tariff quotas that are managed in accordance with the first come, first served principle, where the amendment of quantities leads to either an increase of the quantity of a tariff quota that was exhausted or to a decrease of the available quantity of a tariff quota for products that were already released for free circulation in the Union. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets, |
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Implementing Regulation (EU) 2020/761
Annexes II, III, VIII, and X are amended in accordance with Annex I to this Regulation.
Article 2
Amendment to Implementing Regulation (EU) 2020/1988
Annex I is amended in accordance with Annex II to this Regulation.
Article 3
Transitional provisions
1. With regard to the amendments introduced by Article 1, where the tariff quota period of a given tariff quota has already started on the day of entry into force of this Regulation, the difference between the new quantity and the quantity already allocated shall be made available:
(a) |
from the first application period after the entry into force of this Regulation, if the tariff quota period is not divided into sub-periods; |
(b) |
according to the specific rules applicable to each tariff quota, if the tariff quota has a period divided in sub-periods. |
If one or more sub-periods have already expired at the moment of the entry into force of this Regulation, the difference between the new quantity available in the sub-periods expired before the entry into force of this Regulation and the quantity actually allocated shall be made available as from the first application period after the entry into force of this Regulation.
2. With regard to the amendments introduced by Article 2, the difference between the new quantity and the quantity already released for free circulation before the entry into force of this Regulation shall be made available from the day of entry into force of this Regulation.
In case of an increase of the quantity set out in Annex I to Implementing Regulation (EU) 2020/1988, if on the day of entry into force of this Regulation the relevant tariff quota period has already started and the quantity previously available is exhausted, the difference between the new quantity and the previous quantity shall be allocated to operators following the chronological order of the acceptance date of the customs declaration for release for free circulation. Operators who imported their goods out of quota before the entry into force of this Regulation, and who will benefit of the allocation of the additional quantity, shall be reimbursed the difference between the duty already paid and the in-quota duty.
In case of a decrease of the quantity set out in Annex I to Implementing Regulation (EU) 2020/1988, if on the day of entry into force of this Regulation the relevant tariff quota period has already started and a quantity higher than the new one has already been released for free circulation, operators shall not be required to pay any additional duty for the in-quota quantities imported exceeding the new available volumes.
Article 4
Entry into force and application
This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.
Article 1 shall apply from the first licence application period starting after the entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 347, 20.12.2013, p. 671.
(2) Commission Implementing Regulation (EU) 2020/761 of 17 December 2019 laying down rules for the application of Regulations (EU) No 1306/2013, (EU) No 1308/2013 and (EU) No 510/2014 of the European Parliament and of the Council as regards the management system of tariff quotas with licences (OJ L 185, 12.6.2020, p. 24).
(3) Commission Implementing Regulation (EU) 2020/1988 of 11 November 2020 laying down rules for the application of Regulations (EU) No 1308/2013 and (EU) No 510/2014 of the European Parliament and of the Council as regards the administration of import tariff quotas in accordance with the ‘first come, first served’ principle (OJ L 422, 14.12.2020, p. 4).
(4) Council Decision (EU) 2023/912 of 25 April 2023 on the conclusion, on behalf of the Union, of the Agreement between the European Union and the United States of America pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU schedule CLXXV as a consequence of the United Kingdom’s withdrawal from the European Union (OJ L 119, 5.5.2023, p. 1).
ANNEX I
Annexes I, II, III, VIII, and X to Implementing Regulation (EU) 2020/761 are amended as follows:
(1) |
in Annex I, the row relating to the tariff quota with order number 09.4170 is deleted; |
(2) |
in Annex II, in the table relating to the tariff quota with order number 09.4123, the row ‘Quantity in kg’ is replaced by the following:
|
(3) |
Annex III is amended as follows:
|
(4) |
in Annex VIII, in the table relating to the tariff quota with order number 09.4002, the row ‘Quantity in kg’ is replaced by the following:
|
(5) |
Annex X is amended as follows:
|
ANNEX II
Annex I to Implementing Regulation (EU) 2020/1988 is amended as follows:
(1) |
the section under the heading ‘Tariff quotas in the sector of cereals’ is amended as follows:
|
(2) |
in the section under the heading ‘Tariff quotas in the sector of rice’, in the table relating to the tariff quota with order number 09.0083, the row ‘Quantity’ is replaced by the following:
|
(3) |
the section under the heading ‘Tariff quotas in the sector of fruits and vegetables’ is amended as follows:
|
(4) |
in the section under the heading ‘Tariff quotas in the sector of processed fruits and vegetables’, in the table relating to the tariff quota with order number 09.0093, the row ‘Quantity’ is replaced by the following:
|
(5) |
in the section under the heading ‘Tariff quotas in the sector of milk and milk products’, in the table relating to the tariff quota with order number 09.0147, the row ‘Quantity’ is replaced by the following:
|
(6) |
in the section under the heading ‘Tariff quotas in the sector of pigmeat’, in the table relating to the tariff quota with order number 09.0123, the row ‘Quantity’ is replaced by the following:
|
(7) |
in the section under the heading ‘Tariff quotas in the sector of other products listed in Section 2 of Part XXIV of Annex I to Regulation (EU) No 1308/2013’, in the table relating to the tariff quota with order number 09.0055, the row ‘Quantity’ is replaced by the following:
|
12.6.2023 |
EN |
Official Journal of the European Union |
L 151/11 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1143
of 9 June 2023
granting a Union authorisation for the single biocidal product ‘Chemisept IPA-N’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,
Whereas:
(1) |
On 24 April 2019, AS Chemi-Pharm submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Chemisept IPA-N’, of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-UU051173-14 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22. |
(2) |
The same single biocidal product ‘Chemisept IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1. |
(3) |
On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Chemisept IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. |
(4) |
The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. |
(5) |
On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
(6) |
The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Chemisept IPA-N’. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
A Union authorisation with authorisation number EU-0027678-0000 is granted to AS Chemi-Pharm for the making available on the market and use of the same single biocidal product ‘Chemisept IPA-N’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 2 July 2023 until 31 July 2032.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).
(3) ECHA opinion for ‘Chemisept IPA-N’, 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation
(4) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).
ANNEX
Summary of product characteristics for a biocidal product
Chemisept IPA-N
Product type 1 – Human hygiene (Disinfectants)
Authorisation number: EU-0027678-0000
R4BP asset number: EU-0027678-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
Trade name(s) |
Chemisept IPA-N |
1.2. Authorisation holder
Name and address of the authorisation holder |
Name |
Chemi-Pharm AS |
Address |
Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia |
|
Authorisation number |
EU-0027678-0000 |
|
R4BP asset number |
EU-0027678-0000 |
|
Date of the authorisation |
2.7.2023 |
|
Expiry date of the authorisation |
31.7.2032 |
1.3. Manufacturer(s) of the product
Name of manufacturer |
AS Chemi-Pharm |
Address of manufacturer |
Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
Location of manufacturing sites |
AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
1.4. Manufacturer(s) of the active substance(s)
Active substance |
Propan-1-ol |
Name of manufacturer |
OQ Chemicals GmbH (formerly Oxea GmbH) |
Address of manufacturer |
Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
Location of manufacturing sites |
OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |
Active substance |
Propan-1-ol |
Name of manufacturer |
BASF SE |
Address of manufacturer |
Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Location of manufacturing sites |
BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Active substance |
Propan-1-ol |
Name of manufacturer |
SASOL Chemie GmbH & Co. KG |
Address of manufacturer |
Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
Location of manufacturing sites |
Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |
Active substance |
Propan-2-ol |
Name of manufacturer |
INEOS Solvent Germany GmbH |
Address of manufacturer |
Römerstrasse 733, 47443 Moers Germany |
Location of manufacturing sites |
INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany |
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
2.2. Type of formulation
AL – Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
Flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
Precautionary statements |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4. AUTHORISED USE(S)
4.1. Use description
Table 1
Use # 1 – hygienic handrub, liquid
Product type |
PT01 – Human hygiene (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Mycobacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data |
||||||
Field(s) of use |
Indoor
|
||||||
Application method(s) |
Method: Manual application Detailed description: Rubbing |
||||||
Application rate(s) and frequency |
Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml) Contact time: 30 s Dilution (%): Ready-to-use product Number and timing of application: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
||||||
Category(ies) of users |
Industrial Professional |
||||||
Pack sizes and packaging material |
100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.1.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
Do not refill.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 2
Use # 2 – surgical handrub, liquid
Product type |
PT01 – Human hygiene (Disinfectants) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Mycobacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: enveloped viruses Development stage: no data |
Field(s) of use |
Indoor Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms. For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Rubbing |
Application rate(s) and frequency |
Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact time: 90 s Dilution (%): Ready-to-use product Number and timing of application: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.2.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
4.2.2. Use-specific risk mitigation measures
See general directions for use.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE (1)
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0– 30 °C
Do not store at temperatures below 0 °C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
12.6.2023 |
EN |
Official Journal of the European Union |
L 151/20 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1144
of 9 June 2023
granting a Union authorisation for the single biocidal product ‘Bacticid IPA-N’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,
Whereas:
(1) |
On 24 April 2019, Chemi-Pharm AS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Bacticid IPA-N’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-SM051156-28 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22. |
(2) |
The same single biocidal product ‘Bacticid IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. |
(3) |
On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Bacticid IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. |
(4) |
The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. |
(5) |
On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
(6) |
The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Bacticid IPA-N’. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS REGULATION:
Article 1
A Union authorisation with authorisation number EU-0027679-0000 is granted to Chemi-Pharm AS for the making available on the market and use of the same single biocidal product ‘Bacticid IPA-N’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 2 July 2023 until 31 July 2032.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 167, 27.6.2012, p. 1.
(2) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).
(3) ECHA opinion for ‘Bacticid IPA-N’, 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation
(4) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).
ANNEX
Summary of product characteristics for a biocidal product
Bacticid IPA-N
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0027679-0000
R4BP asset number: EU-0027679-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
Trade name(s) |
Bacticid IPA-N |
1.2. Authorisation holder
Name and address of the authorisation holder |
Name |
Chemi-Pharm AS |
Address |
Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia |
|
Authorisation number |
EU-0027679-0000 |
|
R4BP asset number |
EU-0027679-0000 |
|
Date of the authorisation |
2.7.2023 |
|
Expiry date of the authorisation |
31.7.2032 |
1.3. Manufacturer(s) of the product
Name of manufacturer |
AS Chemi-Pharm |
Address of manufacturer |
Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
Location of manufacturing sites |
AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
1.4. Manufacturer(s) of the active substance(s)
Active substance |
Propan-1-ol |
Name of manufacturer |
OQ Chemicals GmbH (formerly Oxea GmbH) |
Address of manufacturer |
Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
Location of manufacturing sites |
OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |
Active substance |
Propan-1-ol |
Name of manufacturer |
BASF SE |
Address of manufacturer |
Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Location of manufacturing sites |
BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Active substance |
Propan-1-ol |
Name of manufacturer |
SASOL Chemie GmbH & Co. KG |
Address of manufacturer |
Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
Location of manufacturing sites |
Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |
Active substance |
Propan-2-ol |
Name of manufacturer |
INEOS Solvent Germany GmbH |
Address of manufacturer |
Römerstrasse 733, 47443 Moers Germany |
Location of manufacturing sites |
INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany |
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
35,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
35,0 |
2.2. Type of formulation
AL – Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
Flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
Precautionary statements |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. Wear eye protection.. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4. AUTHORISED USE(S)
4.1. Use description
Table 1
Use # 1 – hard non-porous small surface disinfection RTU liquid
Product type |
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: viruses (limited spectrum virucidal activity) Development stage: no data |
Field(s) of use |
Indoor Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces. For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20 ± 2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2 to keep the surface wet during the contact time. |
Application rate(s) and frequency |
Application Rate: Minimum exposure time: — for the control of bacteria, yeasts and enveloped viruses: 60 sec — for the control of viruses (limited spectrum virucidal activity): 5 min Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use
4.2. Use description
Table 2
Use # 2 – hard non-porous small surface disinfection RTU liquid
Product type |
PT04 – Food and feed area (Disinfectants) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
Field(s) of use |
Indoor Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants: disinfection of small hard/non-porous surfaces. For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Ready-to-use surface disinfectant at room temperature (20 ± 2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. |
Application rate(s) and frequency |
Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec Dilution (%): Ready-to-use product Number and timing of application: The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head); 5 000 ml transparent/white HDPE canister with HDPE screwed cap. |
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE (1)
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
The use of eye protection during handling of the product is mandatory.
Keep out of reach of children
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0– 30 °C
Do not store at temperatures below 0 °C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
DECISIONS
12.6.2023 |
EN |
Official Journal of the European Union |
L 151/28 |
COMMISSION IMPLEMENTING DECISION (EU) 2023/1145
of 7 June 2023
amending Implementing Decision (EU) 2022/2333 concerning certain emergency measures relating to sheep pox and goat pox in Spain
(notified under document C(2023)3806)
(Only the Spanish text is authentic)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 259(1) thereof,
Whereas:
(1) |
Commission Implementing Decision (EU) 2022/2333 (2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down emergency measures relating to outbreaks of sheep pox and goat pox in Spain, that were detected in the regions of Andalusia and Castilla-La Mancha, where they form two distinct clusters, one in each region. That Implementing Decision applies until 31 October 2023. |
(2) |
More particularly, Implementing Decision (EU) 2022/2333 provides that the protection, surveillance and further restricted zones, to be established by Spain following outbreaks of sheep pox and goat pox, in accordance with Article 21 of Commission Delegated Regulation (EU) 2020/687 (3), are to comprise at least the areas listed in the Annex to that Implementing Decision. |
(3) |
In addition to the protection and surveillance zones, a further restricted zone was established, in accordance with Article 21(1), point (c), of Delegated Regulation (EU) 2020/687, in both the regions of Andalusia and Castilla-La Mancha, where Spain is required to apply certain measures regarding restrictions on the movements of sheep and goats outside that further restricted zone, with a view to preventing the spread of sheep pox and goat pox to the rest of its territory and to the rest of the Union. |
(4) |
After the adoption of Implementing Decision (EU) 2022/2333, Spain notified the Commission of a number of additional outbreaks of sheep pox and goat pox in establishments where sheep and/or goats were kept. As a result, the areas listed as protection and surveillance zones, as well as the areas listed as further restricted zones for Spain, in the Annex to Implementing Decision (EU) 2022/2333, were subsequently amended. The last amendment to that Annex was made by the Commission Implementing Decision 2023/872 (4). |
(5) |
Since the date of adoption of Implementing Decision (EU) 2023/872, Spain has notified the Commission of one additional outbreak of sheep pox and goat pox in establishments where sheep and/or goats were kept, in the region of Castilla-La Mancha, more specifically in the Province of Cuenca, outside the surveillance zone already established in that region. |
(6) |
The competent authority of Spain has taken the necessary disease control measures required in accordance with Delegated Regulation (EU) 2020/687, including the establishment of protection and surveillance zones around the new outbreak. Spain has also maintained the previously established restricted zones, around the previous outbreaks, recorded since the beginning of 2023 in Castilla-La Mancha, in the Province of Ciudad Real. |
(7) |
Therefore, the areas listed as protection, surveillance and further restricted zones for Spain in the Annex to Implementing Decision (EU) 2022/2333 should be amended, spatially and temporally, taking into account the current epidemiological situation as regards sheep pox and goat pox in the region of Castilla-La Mancha. |
(8) |
Given the urgency of the epidemiological situation in the Union as regards the spread of sheep pox and goat pox, it is important that the amendments to be made to the Annex to Implementing Decision (EU) 2022/2333 by this Decision take effect as soon as possible. |
(9) |
In addition, taking into account the current epidemiological situation in the Union as regards sheep pox and goat pox, the period of application of Implementing Decision (EU) 2022/2333 should be prolonged until 31 December 2023. |
(10) |
Implementing Decision (EU) 2022/2333 should therefore be amended accordingly. |
(11) |
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS DECISION:
Article 1
Amendments to Implementing Decision (EU) 2022/2333
Implementing Decision (EU) 2022/2333 is amended as follows:
1. |
Article 5 is replaced by the following: ‘Article 5 Application This Decision shall apply until 31 December 2023.’ |
2. |
the Annex to Implementing Decision (EU) 2022/2333 is replaced by the text set out in the Annex to this Decision. |
Article 2
Addressee
This Decision is addressed to the Kingdom of Spain.
Done at Brussels, 7 June 2023.
For the Commission
Stella KYRIAKIDES
Member of the Commission
(2) Commission Implementing Decision (EU) 2022/2333 of 23 November 2022 concerning certain emergency measures relating to sheep pox and goat pox in Spain and repealing Implementing Decision (EU) 2022/1913 (OJ L 308, 29.11.2022, p. 22).
(3) Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64).
(4) Commission Implementing Decision (EU) 2023/872 of 20 April 2023 amending Implementing Decision (EU) 2022/2333 concerning certain emergency measures relating to sheep pox and goat pox in Spain (OJ L 113, 28.4.2023, p. 49).
ANNEX
‘ANNEX
A. Protection and surveillance zones established around confirmed outbreaks
Region and ADIS reference number of the outbreak |
Areas established as protection and surveillance zones, part of the restricted zones in Spain as referred to in Article 1 |
Date until applicable |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Region of Castilla–La Mancha ES-CAPRIPOX-2023-00003 ES-CAPRIPOX-2023-00004 ES-CAPRIPOX-2023-00005 ES-CARPIPOX-2023-00006 ES-CARPIPOX-2023-00007 |
Protection zone: A protection zone that comprises the following areas: In the province of Ciudad Real the municipalities of:
In the province of Albacete the municipality of:
In province of Cuenca the municipalities of:
|
20.7.2023 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Surveillance zone: A surveillance zone that comprises the following areas: In the province of Ciudad Real the municipalities of:
In the province of Toledo the municipalities of:
In the province of Cuenca the municipalities of:
In the province of Albacete the municipalities of:
|
7.8.2023 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Surveillance zone: A surveillance zone that comprises the following areas: In the province of Ciudad Real the municipalities of:
In the province of Albacete the municipality of:
In province of Cuenca the municipalities of:
|
21.7.2023-7.8.2023 |
B. Further restricted zones
Region |
Areas established as further restricted zones, part of the restricted zones in Spain as referred to in Article 1 |
Date until applicable |
||||||||
Region of Castilla–La Mancha |
A further restricted zone that comprises the following provinces:
|
25.9.2023 |
ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS
12.6.2023 |
EN |
Official Journal of the European Union |
L 151/33 |
DECISION No 1/2023 OF THE JOINT COMMITTEE ESTABLISHED BY THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE UNITED STATES OF AMERICA
of 26 May 2023
on the mutual recognition of certificates of conformity for marine equipment amending Annexes I, II and III [2023/1146]
THE JOINT COMMITTEE,
Having regard to the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment, and in particular Article 7 thereof;
Whereas:
(1) |
Pursuant to Article 7(3)(d) of the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment (‘the Agreement’), the Joint Committee established under Article 7(1) of the Agreement may amend the Annexes thereto. |
(2) |
In order to support the proper implementation of the legislation that is within the scope of the Agreement it is important to include interpretations developed by the notified body coordination group established under Directive 2014/90/EU of the European Parliament and of the Council (1) as well as policy guidance issued by the U.S. Coast Guard in the list of laws, regulations and administrative provisions listed in Annex I. |
(3) |
Therefore, Annex I to the Agreement should be amended accordingly. |
(4) |
In accordance with Article 7(3)(a) of the Agreement, the Joint Committee is responsible for developing and maintaining the list in Annex II of products and associated legislative, regulatory and administrative provisions that the Parties have determined to be equivalent. |
(5) |
Taking into account technical progress and changes to the international instruments, the European Union and the United States of America have agreed on the modification of the product coverage for mutual recognition. |
(6) |
Therefore, Annex II of the Agreement should be amended accordingly. |
(7) |
The list of regulatory authorities and their addresses should be updated and the regulatory authority of the United Kingdom should be removed. |
(8) |
Therefore, Annex III of the Agreement should be amended accordingly, |
HAS DECIDED AS FOLLOWS:
Annexes I, II and III of the Agreement are replaced by the text in the Annex to this Decision.
This Decision, done in duplicate, shall be signed by representatives of the Joint Committee who are authorised to act on behalf of the Parties for purposes of amending the Agreement. This Decision shall be effective from the date of the later of these signatures.
On behalf of the United States of America
Sushan DEMIRJIAN
Signed in Brussels, on 26 May 2023
On behalf of the European Union
Lucian CERNAT
Signed in Brussels, on 26 May 2023
(1) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
ANNEX
‘ANNEX I
LEGISLATION, REGULATIONS AND ADMINISTRATIVE PROVISIONS
EU legislation, regulations and administrative provisions:
— |
Directive 2014/90/EU (hereinafter referred to as ‘MED’) and the implementing acts adopted in accordance with Articles 35(2) and (3) of that Directive, which are published in the Official Journal of the European Union and made available on https://portal.med.emsa.europa.eu/. |
— |
Guidelines for the implementation of, in particular, conformity assessment procedures falling under the MED are provided by:
|
U.S. legislation, regulations and administrative provisions:
— |
United States Code, Title 46 (46 U.S.C. 3306), provides statutory authority to the United States Coast Guard (through delegation by the Secretary of the Department of Homeland Security) to issue regulations for approval of marine equipment. |
— |
United States Code of Federal Regulations
|
— |
Policy guidance issued by the U.S. Coast Guard
|
‘ANNEX II
PRODUCT COVERAGE FOR MUTUAL RECOGNITION
Lifesaving appliances
Product item identification |
EU item number |
U.S. item |
Position- indicating lights for life- saving appliances: for survival craft and rescue boats |
MED/1.2a |
161.101 |
Position- indicating lights for life- saving appliances: for lifebuoys |
MED/1.2b |
161.110 |
Position- indicating lights for life- saving appliances: for lifejackets |
MED/1.2c |
161.112 |
Lifebuoy self- activating smoke signals Note: Expiration date not to exceed 48 months after month of manufacture. |
MED/1.3 |
160.157 |
Rocket parachute flares (pyrotechnics) Note: Expiration date not to exceed 48 months after month of manufacture. |
MED/1.8 |
160.136 |
Hand flares (pyrotechnics) Note: Expiration date not to exceed 48 months after month of manufacture. |
MED/1.9 |
160.121 |
Buoyant smoke signals (pyrotechnics) Note: Expiration date not to exceed 48 months after month of manufacture. |
MED/1.10 |
160.122 |
Line-throwing appliances Note: Expiration date not to exceed 48 months after month of manufacture. |
MED/1.11 |
160.040 |
Rigid liferafts Note: The emergency pack is not covered by the Agreement |
MED/1.13 |
160.118 |
Automatically self- righting liferafts (rigid liferafts only/inflatable liferafts not covered) Note: The emergency pack is not covered by the Agreement |
MED/1.14b |
160.118 |
Canopied reversible liferafts (rigid liferafts only/inflatable liferafts not covered) Note: The emergency pack is not covered by the Agreement |
MED/1.15 |
160.118 |
Float- free arrangements for liferafts (hydrostatic release units) |
MED/1.16 |
160.162 |
Release mechanism for: Lifeboats and rescue boats (launched by a fall or falls) Limited to Davit-launched liferaft automatic release hook |
MED/1.26a |
160.170 |
Release mechanism for: Liferafts (launched by a fall or falls) Limited to Davit-launched liferaft automatic release hook |
MED/1.26b |
160.170 |
Marine evacuation systems |
MED/1.27 |
160.175 |
Embarkation Ladders |
MED/1.29 |
160.117 |
Retro-reflective materials |
MED/1.30 |
164.018 |
Fire protection
Product item identification |
EU item number |
U.S. item number |
Primary deck coverings |
MED/3.1 |
164.106 |
‘A’ & ‘B’ Class divisions fire integrity: ‘A’ class divisions: A-60 deck assemblies |
MED/3.11a |
164.105 |
‘A’ & ‘B’ Class divisions fire integrity: ‘A’ class divisions: A-60 structural insulation |
MED/3.11a |
164.107 |
‘A’ & ‘B’ Class divisions fire integrity: ‘B’ class divisions. - bulkheads. |
MED/3.11b |
164.108 |
‘A’ & ‘B’ Class divisions fire integrity: ‘B’ class divisions. - ceilings. |
MED/3.11b |
164.110 |
Non-combustible materials |
MED/3.13 |
164.109 |
Fire doors Limited to fire doors without windows or with total window area no more than 645 cm2 in each door leaf, unless hose stream, heat flux, and/or temperature rise tests are conducted according to USCG approval guidance. Approval limited to maximum door size tested. Doors must be used with a fire tested frame design. |
MED/3.16 |
164.136 |
Fire door control systems components. |
MED/3.17 |
164.146 |
Surface materials and floor coverings with low flame-spread characteristics: decorative veneers. |
MED/3.18a |
164.112 |
Surface materials and floor coverings with low flame-spread characteristics: paint systems. |
MED/3.18b |
164.112 |
Surface materials and floor coverings with low flame-spread characteristics: floor coverings. |
MED/3.18 c |
164.117 |
Surface materials and floor coverings with low flame-spread characteristics: combustible ducts membrane. |
MED/3.18f |
164.112 |
Draperies, curtains and other suspended textile materials and films |
MED/3.19 |
164.111 |
Upholstered furniture: Cover material for flame-retardant filling material |
MED/3.20b |
164.144 |
Upholstered furniture: Cover material for flame-retardant filling material (tested in specific combination as intended for the later application). |
MED/3.20c |
164.144 |
Bedding components |
MED/3.21 |
164.142 |
Fire dampers |
MED/3.22 |
164.139 |
Penetrations through ‘A’ class electric cable transits. |
MED/3.26a |
164.138 |
Penetrations through ‘A’ class pipe, duct, trunk, etc. penetrations |
MED/3.26b |
164.138 |
Fire restricting materials (except furniture) for high-speed craft |
MED/3.32 |
164.201 |
Fire restricting materials for furniture for high-speed craft |
MED/3.33 |
164.201 |
Fire resisting divisions for high-speed craft |
MED/3.34 |
164.207 |
C class divisions |
MED/3.64 |
164.109 |
Navigation equipment
Product item identification |
EU item |
US item number |
Magnetic compass Class A for ships |
MED/4.1 |
165.101 |
Transmitting heading device THD (magnetic method) |
MED/4.2 |
165.102 |
Echo-sounding equipment |
MED/4.6 |
165.107 |
Speed and distance measuring equipment (SDME) |
MED/4.7 |
165.105 |
Rate- of- turn- indicator |
MED/4.9 |
165.106 |
Heading control system (HCS) |
MED/4.16 |
165.110 |
Rudder Angle Indicator |
MED/4.20 |
165.167 |
Propeller revolution indicator |
MED/4.21 |
165.168 |
Pitch Indicator |
MED/4.22 |
165.169 |
Voyage data recorder (VDR) |
MED/4.29 |
165.150 |
Electronic chart display and information system (ECDIS) with backup, and raster chart display system (RCDS) |
MED/4.30 |
165.123 165.124 |
Universal automatic identification system equipment (AIS) |
MED/4.32 |
165.155 |
Track control system (working at ship’s speed from minimum manoeuvring speed up to 30 knots) |
MED/4.33 |
165.112 |
Radar reflector passive type |
MED/4.39 |
165.160 |
Heading control system for high-speed craft |
MED/4.40 |
165.210 |
Transmitting heading device THD (GNSS method) |
MED/4.41 |
165.102 |
Searchlight for high-speed craft |
MED/4.42 |
165.252 |
Night vision equipment for high-speed craft |
MED/4.43 |
165.251 |
Transmitting heading device THD (Gyroscopic method) |
MED/4.46 |
165.102 |
Simplified voyage data recorder (S- VDR) |
MED/4.47 |
165.151 |
Pilot ladder |
MED/4.49 |
163.003 |
Daylight signaling lamp |
MED/4.52 |
165.166 |
Bridge Navigational Watch Alarm System (BNWAS) |
MED/4.57 |
165.142 |
Sound reception system |
MED/4.58 |
165.165 |
Integrated navigation system |
MED/4.59 |
165.141 |
GPS equipment |
MED/4.63 |
165.130 |
GLONASS equipment |
MED/4.63 |
165.131 |
DGPS equipment |
MED/4.63 |
165.132 |
DGLONASS equipment |
MED/4.63 |
165.133 |
Radar equipment CAT 1 (Radar equipment used with ARPA must have separate EU and USA certifications) ‡ |
MED/4.64 |
165.115 |
Radar equipment CAT 2 (Radar equipment used with ATA must have separate EU and USA certifications) ‡ |
MED/4.64 |
165.116 |
Radar equipment CAT 3 (Radar equipment used with EPA must have separate EU and USA certifications) ‡ |
MED/4.64 |
165.117 |
Radar equipment for high-speed craft applications (CAT 1H) ‡ |
MED/4.64 |
165.216 |
Radar equipment for high-speed craft applications (CAT 2H) ‡ |
MED/4.64 |
165.217 |
Gyro compass |
MED/4.65 |
165.103 |
Gyro compass for high-speed craft |
MED/4.65 |
165.203 |
‘ANNEX III
REGULATORY AUTHORITIES
EUROPEAN UNION
Belgium |
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Bulgaria |
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Czech Republic |
Ministerstvo dopravy (Ministry of Transport) P.O. Box 9 Nábřeží Ludvíka Svobody 12 110 15 Praha 1 |
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Denmark |
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Germany |
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Estonia |
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Ireland |
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Greece |
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Spain |
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France |
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Croatia |
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Italy |
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Cyprus |
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Latvia |
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Lithuania |
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Luxembourg |
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Hungary |
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Malta |
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Netherlands |
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Austria |
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Poland |
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Portugal |
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Romania |
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Slovenia |
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Slovakia |
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Finland |
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Sweden |
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European Commission |
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UNITED STATES OF AMERICA |
United States Coast Guard |
Office of Design and Engineering Standards (CG- ENG) |
2703 Martin Luther King Jr Ave SE |
STOP 7509 |
Washington DC 20593-7509 |